Less cutting, same cure? new trial tests smaller surgery for rectal cancer
NCT ID NCT07038122
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether surgeons can safely remove less tissue during surgery for upper rectal cancer after patients have received pre-surgery therapy. About 874 adults with locally advanced rectal cancer will be randomly assigned to either standard or reduced surgical margins. The goal is to see if the smaller surgery is as effective at preventing cancer from coming back while being safer and easier to recover from.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- laparoscopic surgery with reduced resection margins
- What this could lead to
- If successful, this could allow surgeons to remove less tissue while still effectively treating rectal cancer, leading to faster recovery and fewer complications.
- What could go wrong
- This is an early-stage trial with 874 participants, and the reduced margins might not be as effective as standard surgery in preventing cancer return. Risks include surgical complications like leakage or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 874 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-80 years. 2. Histopathologically confirmed adenocarcinoma of the rectum or rectosigmoid junction. 3. Clinical stage cT3-4N+M0, with or without positive mesorectal fascia (MRF), with or without extramural vascular invasion (EMVI); Tumor location confirmed by imaging to be above the peritoneal reflection and by endoscopy to be in the upper rectum or rectosigmoid junction. 4. For patients with pMMR (proficient Mismatch Repair; immunohistochemistry shows expression of all four proteins: MSH1, MSH2, MSH6, PMS2) or MSS (Microsatellite Stable) status: Tumor downstaged to T≤3N0M0 after neoadjuvant chemotherapy or total neoadjuvant therapy (TNT). Chemotherapy regimens include, but are not limited to, FOLFOX6, CAPOX, or FOLFOXIRI. 5. For patients with dMMR (deficient Mismatch Repair; immunohistochemistry shows loss of expression in two or more of MSH1, MSH2, MSH6, PMS2) or MSI-H (Microsatellite Instability-High) status: Tumor downstaged to T≤3N0M0 after immunotherapy. 6. Pre-neoadjuvant therapy / Preoperative staging methods: All patients underwent contrast-enhanced CT for staging. Peri-rectal metastatic lymph nodes: defined as nodes with short-axis diameter ≥10 mm or exhibiting CT characteristics typical of metastasis. Preoperative chest, abdominal CT, and pelvic MRI ruling out distant metastasis. 7. No signs of bowel obstruction; OR bowel obstruction that has resolved following proximal diverting colostomy. 8. No prior colorectal surgery. 9. No prior chemotherapy or radiotherapy. 10. No prior treatment with biologic agents (e.g., monoclonal antibodies), immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies), or other investigational drugs. 11. Prior endocrine therapy: Allowed. 12. Signed informed consent form. Exclusion Criteria: 1. History of malignant colorectal tumor(s). 2. Requiring emergent surgery (e.g., due to bowel obstruction or intestinal hemorrhage). 3. Primary tumor invading adjacent organs/tissues precluding R0 resection. 4. Multifocal primary tumors. 5. Concurrent diagnosis of other active malignancy. 6. Participation in other clinical trials within 4 weeks prior to enrollment or current participation. 7. ASA physical status classification ≥ IV and/or ECOG performance status ≥ 2 (see Appendix for details). 8. Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction, or significant comorbidities contraindicating surgery. 9. History of severe psychiatric disorders. 10. Pregnancy or lactation. 11. Uncontrolled preoperative infection. 12. Other clinical or laboratory conditions deemed by the investigator to render the patient unsuitable for the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
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Other studies related to the condition(s) this trial covers.
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